Warnings on fluoroquinolones, antipsychotics, becaplermin

Recalls, warnings and alerts

A boxed warning about an increased risk of developing tendinitis and tendon rupture with fluoroquinolone antimicrobial drugs. The risk is heightened in those over age 60; in kidney, heart and lung transplant recipients; and in those using concomitant steroids. Patients with symptoms should stop using the drug at the first sign of tendon pain, swelling or inflammation, avoid using or exercising the area, and call their doctors about switching drugs.

A recall of lots 856396A and 856693A of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL unit dose bottles, used to treat hyperkalemia. A sample from lot 856396A tested positive for a strain of yeast, which could cause infection in immunocompromised patients.

A recall of some lots of 2% chlorhexidine gluconate cloth patient preoperative skin preparation product because some tested positive for Burkholderia cepacia, which can cause respiratory infections in susceptible patients. The recalled lots are 10722, 10729, 10718, 10357, 10365, 10641, 10672, 10753, 10755 and 10944.

A boxed warning for conventional antipsychotics about an increased risk of death associated with their off-label use in patients with dementia-related psychosis. Atypical antipsychotics carry this risk, as well.

A change in prescribing information to reflect that mycophenolate mofetil (CellCept, Myfortic) may carry a heightened risk of progressive multifocal leukoencephalopathy (PML) for transplant recipients. Doctors should consider PML as a cause if patients develop neurologic symptoms, and possibly consult a neurologist.

Vials of Genentech's Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent should be inspected in light of an increased number of complaints about damaged and broken vials of NDC# 50242-0134-68, List # 15534, which can lead to a loss in sterility and patient infections.

A boxed warning for becaplermin (Regranex Gel 0.01%) reflecting an increased risk of cancer death in diabetic patients who used three or more tubes of the cream to treat leg and foot ulcers and a fivefold higher risk of cancer death in those who were exposed to three or more tubes of Regranex versus those who weren't.

A revised boxed warning about risks associated with micro-bubble contrast agents Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection). Due to the risk of serious cardiopulmonary reactions during or within 30 minutes of administration of these products, patients with pulmonary hypertension or unstable cardiopulmonary conditions should be closely monitored during this time period.

A recall of lot number 91762 of ETHEX Corp.'s morphine sulfate 60 mg extended release tablets, due to a report of a tablet with twice the appropriate thickness. Such tablets may contain double the dose. The white oval tablet has a “60” on one side and an “E” on the other.

An alert that life-threatening complications are associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine—an unapproved use by the FDA. Complications have involved swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Doctors should use alternate treatments or enroll patients in approved clinical trials.

A warning that the X-rays used during CT exams may cause some external electronic medical devices to malfunction, as has happened in a few cases with pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps.

A warning against combining bevacizumab (Avastin) with sunitinib malate. Several cases of microangiopathic hemolytic anemia (MAHA) have been reported in patients with solid tumors receiving this combination as part of a Phase I trial.

Approvals

The eSensor Warfarin Sensitivity Test to identify patients who may be sensitive to warfarin. The test detects the three genetic markers known to play a critical role in metabolism of warfarin, which in turn helps physicians decide on a dosage level.

The SPOT-Light HER2 CISH genetic test to determine if patients with breast cancer are good candidates for treatment with trastuzumab (Herceptin).

The OneTouch Ping Glucose Management System, the first insulin pump that wirelessly communicates with a remote blood glucose meter so patients can calculate and deliver insulin doses without touching their pumps.

Methylphenidate HCl (Concerta), a once-daily pill to treat attention deficit hyperactivity disorder in adults age 18 and up. It was already approved for children ages 6-17.

Duloxetine HCl (Cymbalta) to treat fibromyalgia. The drug is already approved to treat depression, anxiety, and diabetic peripheral neuropathic pain.

Marketing of the ELISA DR-70 Blood Test, used to detect and monitor post-surgery tumors in patients with colorectal cancer.

Zoledronic acid (Reclast), for preventing new fractures in patients who recently had a low-trauma hip fracture. The once-yearly, intravenous bisphosphonate is already indicated for osteoporosis.

XIENCE V everolimus-eluting coronary stent to treat coronary artery disease.